Predictive Study of Serum Endocan for Hemorrhagic Transformation After Reperfusion Therapies in Acute Ischemic Stroke

NCT05228080 | Unknown

• 1 other identifier: KY20212167
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is the second largest cause of death globally after ischemic heart disease.Of the total number of prevalent strokes, 84.4% are ischemic. Reperfusion therapy is the most important treatment for acute ischemic stroke (AIS) ,including intravenous thrombolysis and/or endovascular treatment.However,the most serious and common complication with reperfusion therapy is hemorrhage transformation(HT),which significantly increases disability and mortality. The fundamental mechanism leading to post-stroke HT is the disruption of the blood brain barrier(BBB) and increase of permeability.Endocan plays a critical role in vascular inflammatory responses by enhances the production of pro-inflammatory cytokines by endothelial cells,the expression of adhesion molecules such as inter-cellular adhesion molecule-1(ICAM-1) and vascular cell adhesion molecule-1(VCAM-1),and the adhesion of leukocytes to endothelial cells. Endocan significantly decreases levels of zonula occludens（ZO-1) and occludin which are tight junction proteins that play major roles in the maintenance of vascular barriers. Endocan could induce vascular endothelial growth factor-A(VEGF-A) and facilitate the binding of VEGF-A to its receptor(VEGFR-2) to enhanced endothelial permeability.Therefore,endocan is a reliable biomarker of endothelial dysfunction, which may be associated with disruption of the BBB. In this context, the investigators hypothesized that elevated pretreatment serum endocan levels might be independently associated with HT after reperfusion therapy in the acute phase of ischemic stroke. Serum endocan,ICAM-1,VCAM-1 and matrix metalloproteinase-9(MMP-9) levels will be determined by enzyme-linked immunosorbent assay(ELISA) in blood samples obtained at baseline (pretreatment) and at 12,24 hours after reperfusion therapy in patients with acute stroke and in healthy subjects.In the present study,the investigators attempt to investigate whether high levels of endocan are associated with HT in patients who received reperfusion therapy.In addition,the investigators explore the association between serum endocan and early neurological deterioration and unfavourable short-term prognosis.

Conditions

Acute Ischemic Stroke

Keywords

endocan; stroke; reperfusion; hemorrhage

Outcome Measures

Primary Outcomes (1)

• Incidence of Hemorrhagic Transformation after reperfusion therapy

  Patients will undergo the cranial CT at 24 to 48 hours after reperfusion therapy to identify intracranial hemorrhage

  At 24 to 48 hours after reperfusion therapy

Secondary Outcomes (2)

• Incidence of early neurological deterioration

  At 24 hours from reperfusion therapy

• Incidence of unfavourable short-term prognosis

  At 90 days after stroke onset

Study Arms (1)

acute ischemic stroke

Diagnostic Test: enzyme-linked immunosorbent assay(ELISA)

Interventions

enzyme-linked immunosorbent assay(ELISA) DIAGNOSTIC_TEST

Peripheral blood samples will be drawn from each patient at study entry (before reperfusion therapy) and at 12,24 hours after reperfusion therapy.Serum will be immediately separated by centrifugation at 3000 rpm for 15 minutes and stored at -80°C. Endocan,ICAM-1,VCAM-1,MMP-9 levels will be determined in duplicate by commercially available enzyme-linked immunosorbent assay (ELISA).

acute ischemic stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients in Xijing Hospital,Yan 'an University Xianyang Hospital and Xianyang First People's Hospital

You may qualify if:

• Clinical diagnosis of acute ischemic stroke and presentation at the hospital within 24h from symptom onset
• Eligibility for intravenous thrombolysis and/or endovascular treatment
• Age ≥18 years

You may not qualify if:

• Administration of intravenous thrombolysis at another hospital in patients who are candidates for endovascular treatment
• Contraindications to intravenous thrombolysis
• Contraindications to iodinated contrast agent
• A history of ischemic stroke in three months
• Clinical diagnosis of autoimmune,inflammatory, hematological, or infectious diseases
• Clinical diagnosis of cancer
• Clinical diagnosis of severe cardiac,pulmonary,renal or liver failure
• Clinical diagnosis of dementia or psychosis
• Pregnant and lactating women

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

JIA-NING WU

CONTACT

15353390103; wjn19961230@yeah.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2021
• First Posted: February 8, 2022
• Study Start: December 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: February 1, 2023
• Last Updated: June 1, 2022

Record last verified: 2021-11

Locations

CN (1)